Quality Assurance: Compounding Record Audits for Error Prevention

Author(s):  Hawkins Jessica

Issue:  May/Jun 2023 - Volume 27, Number 3
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Abstract:  This article looks at taking a proactive approach in discovering inconsistencies in pharmaceutical compounding at a facility level. Details on the requirements for master formulation and compounding records in nonsterile and sterile compounding as laid out in the 2022 publications of United States Pharmacopeia Chapter <795> Pharmaceutical Compounding— Nonsterile Preparations and United States Pharmacopeia Chapter <797> Pharmaceutical Compounding—Sterile Preparations are reviewed. Following this summary, information is then presented on how to utilize the record-keeping requirements to a facility’s advantage through regular auditing and reporting and how to incorporate these audits or reports into a facility’s quality-assurance program to fulfill error detection and prevention requirements.

Related Keywords: quality assurance, master formulation records, compounding documentation, United States Pharmacopeia Chapter <795>, United States Pharmacopeia Chapter <797>, error prevention, error detection, compounding record auditing, compounded nonsterile preparations, compounded sterile preparations, compounding record template, audit summary reports

Related Categories: LEGAL, SOPs, QUALITY CONTROL

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